Ebola Virus Disease Clinical Trial
Official title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Monovalent Ebola Zaire Vaccine (rVSVN4CT1-EBOVGP1) Delivered by Intramuscular Injection in Healthy Adult Subjects
The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response.
Ebola Zaire is a filovirus that has caused devastating epidemics of hemorrhagic fever in
South Africa. Research is underway to create a safe and effective vaccine to protect against
Ebola disease, especially for the military and health care workers. Promising animal studies
with this vaccine indicate safety and immunogenicity, and the vaccine platform used to
deliver the Ebola protein antigen has been successful in creating a safe and protective
immune response in people. Note that only one Ebola protein is used in this vaccine; since
the entire intact Ebola virus is required for infection, it is impossible to get Ebola
disease from this vaccine.
The study targets enrollment of 39 healthy adults. These participants are divided into 3
groups that will be administered one of three dose levels of the vaccine (low, medium,
high). The study participants will receive two doses of vaccine: one on day 1 and the second
on day 28 (1 month). Three participants at each dose level will act as controls and receive
a placebo instead of the active vaccine. A total of 13 visits to the clinic are required
over a period of 26 weeks. The total study is expected to take 9 months.
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